1. The Field of the Invention
This invention is generally related to caps for medical connectors and specifically related to caps used to protect the sterility of separated medical fluid-flow connectors and fluid delivery systems.
2. The Relevant Technology
Catheter-related bloodstream infections are caused by microorganisms in patients with intravascular catheters. These infections are a significant cause of illness and excess medical costs. Approximately 80,000 catheter-related bloodstream infections occur in U.S. intensive care units annually. Additionally, such infections are associated with up to 20,000 deaths per year in the United States alone.
Guidelines from the Centers for Disease Control and Prevention describe various ways to limit catheter-related bloodstream infections in hospital, outpatient and home care settings. The guidelines address issues such as hand hygiene, catheter site care and admixture preparation. However, despite these guidelines, catheter-related bloodstream infections continue to plague our healthcare system at rates essentially unchanged over the past 10 years.
Impregnating catheters with various antimicrobial agents is one approach that has been implemented to prevent these infections. These catheters, however, have given less than satisfactory results. Additionally, some microbes have developed resistance to the various antimicrobial agents.
In another system that is commercially available in Europe, a catheter hub containing an antiseptic chamber is filled with three percent iodinated alcohol. Though it has shown to be effective, the catheter hub is expensive and does not fare as well in a formal cost-benefit analysis.
Caps used for protecting sterility of medical connectors are well known in the medical art. Commonly, protective tip caps are applied to luer connectors of tubing, IV access devices, stopcocks and syringes. Many examples of such tip caps are commercially available. Most commercially available medical tubing sets are packaged with a cap in place to protect the tubing during handling. Caps for other types of connectors, including catheter injection ports, are less common, though also known in the medical capping art.
Caps commonly used to cover medical connectors include a cover that is open at one end, closed at the other end and includes a set of spiraling screw threads (for making a secure and sealed luer-type connection) over an associated bared connector, such as an injection port. The inside of the closed end can be equipped with a plastic capsule that can be ruptured when the cover is affixed to the associated connector. Rupturing of the plastic capsule releases antiseptic agents stored in the capsule, thereby applying the antiseptic agents to accessible portions of the connector.
One of the many examples of medical connectors for which such caps are used are intravascular connectors associated with a fluid pathway, such as a central line. Commonly, a fluid pathway is used to intermittently administer medications to a patient. For example, a fluid pathway, which communicates fluids with a patient's blood stream, may have one or more connectors associated therewith. Each of the fluid pathway connectors can be connected to other connectors, such as a connector associated with an IV bag. In such a situation, the medical connectors, such as luer lock connectors, are connected and disconnected at various times, and may remain disconnected for several minutes or hours. Medical connector caps are used to cover and protect the various medical connectors while the connectors are separated from one another. When the medical connectors are separated from each other, there are two connectors that can require covering by a cap. Therefore, it would be an advantage to have a single connector set that can be used to provide protection for both ends of a separated connection.
Fluid delivery into medical catheters and other devices is also well known in the art. Various fluid reservoirs including bottles, bags, and syringes are commonly attached to catheters via tubing and connectors for the purpose of delivering fluid therein. Factory pre-fill syringes have become increasingly used to limit the practice of filling syringes in healthcare facilities which may increase the risk of infections and medication/dosing errors. Regulating guidelines including USP 797 and highly publicized incidents of IV medication errors have further underscored the need for safer, low volume fluid delivery devices.